Nevirapine Oral suspension

Severe, life-threatening (and in some cases fatal) hepatotoxicity reported, particularly during first 18 weeks of therapy. Patients have presented with nonspecific prodromal signs and symptoms of hepatitis and progressed to hepatic failure; these events often associated with rash. Patients with higher CD4+ T-cell counts and women are at increased risk of these hepatic events. Women with CD4+ T-cell counts >250 cells/mm3 (including pregnant women receiving long-term treatment for HIV infection) are at greatest risk, but hepatotoxicity can occur in both genders, all CD4+ T-cell counts, and at any time during treatment Patients with signs or symptoms of hepatitis or with increased serum transaminase concentrations in conjunction with rash or other systemic symptoms must discontinue nelfinavir and seek immediate medical evaluation.

Essential that patients are monitored intensively during the first 18 weeks of nevirapine therapy to detect potential life-threatening hepatotoxicity or skin reactions. Extra vigilance needed during first 6 weeks since this is period of greatest risk.

Hepatic injury has progressed despite discontinuation of nevirapine in some patients.

Do not restart nevirapine following severe hepatic, skin, or hypersensitivity reactions.

Strictly follow the recommendations regarding use of a low initial nevirapine dosage (Adults: 200 mg once daily for the first 14 days). Initiating therapy with this dosage reduces frequency of rash.

REMS:

FDA approved a REMS for nevirapine to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

Close

What is this medicine?

NEVIRAPINE (ne VYE ra peen) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

kidney disease

liver disease

skin condition or rash

an unusual or allergic reaction to nevirapine, other medicines, foods, dyes, or preservatives

pregnant or trying to get pregnant

breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You may take this medicine with or without food. Shake gently before using. It is best to use an oral dosing syringe to measure and give this medicine. This is very important for doses of 5 ml or less. If a dosing cup is used, take the medicine, then rinse the cup with water and drink the rinse to make sure you get the whole dose. Do not use a household spoon to measure the dose. Household spoons are not accurate. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 15 days old for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

itraconazole

ketoconazole

rifampin

rifapentine

St. John's Wort

This medicine may also interact with the following medications:

female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

Severe liver reactions or skin rashes are seen in some patients taking this medicine. The risk of these reactions is greatest during the first 18 weeks of treatment, but can happen anytime. Be sure to carefully monitor for the side effects listed below and contact your doctor when necessary.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, blisters, itching or hives, swelling of the face, lips, or tongue

dark urine

fever

general ill feeling or flu-like symptoms

light-colored stools

loss of appetite, nausea

muscle or joint aches

right upper belly pain

red or swollen eyes

redness, blistering, peeling or loosening of the skin, including inside the mouth

unusually weak or tired

yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

The Healthline Site, its content, such as text, graphics, images, search results,
and other material contained on the Healthline Site ("Content"), its services, and any information or material
posted on the Healthline Site by third parties are provided for informational purposes only. None of the
foregoing is a substitute for professional medical advice, examination, diagnosis, or treatment. Always seek
the advice of a physician or other qualified healthcare provider with any questions you may have regarding a
medical condition. Never disregard professional medical advice or delay in seeking it because of something you
have read on the Healthline Site. If you think you may have a medical emergency, call your doctor or 911 immediately.
Please read the Terms of Service
for more information regarding use of the Healthline Site.

Nevirapine Resources

Drug Info Tools

Healthline’s mission is to make the people of the world healthier through the power of information. We do this by creating quality health information that is authoritative, approachable, and actionable.

Join more than 30 million monthly visitors like you and let Healthline be your guide to better health.